CA2279625A1 - Sterilization of organs and prostheses with coupling agents - Google Patents

Sterilization of organs and prostheses with coupling agents Download PDF

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Publication number
CA2279625A1
CA2279625A1 CA002279625A CA2279625A CA2279625A1 CA 2279625 A1 CA2279625 A1 CA 2279625A1 CA 002279625 A CA002279625 A CA 002279625A CA 2279625 A CA2279625 A CA 2279625A CA 2279625 A1 CA2279625 A1 CA 2279625A1
Authority
CA
Canada
Prior art keywords
treatment
tissue
sterilization
resistance
prostheses
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002279625A
Other languages
French (fr)
Other versions
CA2279625C (en
Inventor
Jean-Marie Girardot
Marie-Nadia Girardot
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biomedical Design Inc
Original Assignee
Biomedical Design, Inc.
Jean-Marie Girardot
Marie-Nadia Girardot
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biomedical Design, Inc., Jean-Marie Girardot, Marie-Nadia Girardot filed Critical Biomedical Design, Inc.
Publication of CA2279625A1 publication Critical patent/CA2279625A1/en
Application granted granted Critical
Publication of CA2279625C publication Critical patent/CA2279625C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N47/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid
    • A01N47/40—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid the carbon atom having a double or triple bond to nitrogen, e.g. cyanates, cyanamides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0082—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using chemical substances
    • A61L2/0088—Liquid substances

Abstract

Heart valves or other components for replacement of heart or other bodily organs and tissue prostheses or synthetic prosthetic materials are effectively sterilized by treatment with a coupling agent known to create amide linkages between amines and carboxylic acids in the presence of a lower alkanol. Such treatment has been shown to be bactericidal when carried out at 40 °C for over 1 hour. The sterilization treatment preferably employs EDC as a water-soluble coupling agent, plus an optional coupling enhancer such as sulfo NHS or NHS, in the presence of isopropanol or an equivalent alkanol. Such sterilization treatment is preferably carried out at a temperature above ambient temperature in a buffered aqueous solution. The treatment leaves no residuals other than ones which are nontoxic and biocompatible, does not affect the resistance of the tissue to thermal denaturation and to digestion by proteolytic enzymes, and surprisingly also increases the resistance of fixed biological tissue to calcification.
CA002279625A 1997-02-10 1998-02-09 Sterilization of organs and prostheses with coupling agents Expired - Fee Related CA2279625C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US3752897P 1997-02-10 1997-02-10
US60/037,528 1997-02-10
PCT/US1998/002395 WO1998034650A2 (en) 1997-02-10 1998-02-09 Sterilization of organs and prostheses with coupling agents

Publications (2)

Publication Number Publication Date
CA2279625A1 true CA2279625A1 (en) 1998-08-13
CA2279625C CA2279625C (en) 2008-01-29

Family

ID=21894817

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002279625A Expired - Fee Related CA2279625C (en) 1997-02-10 1998-02-09 Sterilization of organs and prostheses with coupling agents

Country Status (7)

Country Link
US (1) US5911951A (en)
EP (1) EP0986405B1 (en)
JP (1) JP4271262B2 (en)
AU (1) AU735988B2 (en)
CA (1) CA2279625C (en)
DE (1) DE69814070T2 (en)
WO (1) WO1998034650A2 (en)

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US20040067157A1 (en) * 1993-07-22 2004-04-08 Clearant, Inc. Methods for sterilizing biological materials
EP0804255B1 (en) * 1994-07-29 2001-10-04 Edwards Lifesciences Corporation Methods for treating implantable biological tissues to mitigate the calcification thereof
US6214054B1 (en) 1998-09-21 2001-04-10 Edwards Lifesciences Corporation Method for fixation of biological tissues having mitigated propensity for post-implantation calcification and thrombosis and bioprosthetic devices prepared thereby
US6521179B1 (en) * 1999-08-11 2003-02-18 Biomedical Design, Inc. Sterilization
FR2800397B1 (en) * 1999-10-27 2002-01-18 Electrolux Syst Blanchisserie METHOD FOR CONTROLLING THE ASEPTIC CHARACTERISTICS OF THE LAUNDRY BEFORE OPENING AT LEAST ONE WASHING MACHINE DOOR
US6471723B1 (en) 2000-01-10 2002-10-29 St. Jude Medical, Inc. Biocompatible prosthetic tissue
US20040086420A1 (en) * 2000-03-23 2004-05-06 Macphee Martin J. Methods for sterilizing serum or plasma
AU2001259031B2 (en) * 2000-03-23 2006-04-13 Clearant, Inc. Methods for sterilizing biological materials
US20020177223A1 (en) * 2001-03-12 2002-11-28 Ogle Mathew F. Methods and compositions for crosslinking tissue
US6682695B2 (en) * 2001-03-23 2004-01-27 Clearant, Inc. Methods for sterilizing biological materials by multiple rates
US7078163B2 (en) * 2001-03-30 2006-07-18 Medtronic, Inc. Process for reducing mineralization of tissue used in transplantation
US6696060B2 (en) * 2001-06-14 2004-02-24 Clearant, Inc. Methods for sterilizing preparations of monoclonal immunoglobulins
US6946098B2 (en) 2001-08-10 2005-09-20 Clearant, Inc. Methods for sterilizing biological materials
US20030031584A1 (en) * 2001-08-10 2003-02-13 Wilson Burgess Methods for sterilizing biological materials using dipeptide stabilizers
US6749851B2 (en) * 2001-08-31 2004-06-15 Clearant, Inc. Methods for sterilizing preparations of digestive enzymes
US7252799B2 (en) * 2001-08-31 2007-08-07 Clearant, Inc. Methods for sterilizing preparations containing albumin
US20030185702A1 (en) * 2002-02-01 2003-10-02 Wilson Burgess Methods for sterilizing tissue
US20030068416A1 (en) * 2001-09-24 2003-04-10 Wilson Burgess Method of lyophylization to reduce solvent content and enhance product recovery
US20030095890A1 (en) * 2001-09-24 2003-05-22 Shirley Miekka Methods for sterilizing biological materials containing non-aqueous solvents
US20110091353A1 (en) * 2001-09-24 2011-04-21 Wilson Burgess Methods for Sterilizing Tissue
US6783968B2 (en) * 2001-09-24 2004-08-31 Clearant, Inc. Methods for sterilizing preparations of glycosidases
US20030124023A1 (en) * 2001-12-21 2003-07-03 Wilson Burgess Method of sterilizing heart valves
US6878168B2 (en) 2002-01-03 2005-04-12 Edwards Lifesciences Corporation Treatment of bioprosthetic tissues to mitigate post implantation calcification
US7918899B2 (en) 2002-01-25 2011-04-05 Biomedical Design, Inc. Variably crosslinked tissue
JP4512370B2 (en) * 2002-01-25 2010-07-28 バイオメディカル デザイン インコーポレイテッド Anti-calcification fixation
US20040013562A1 (en) * 2002-07-18 2004-01-22 Wilson Burgess Methods for sterilizing milk.
US20040013561A1 (en) * 2002-07-18 2004-01-22 David Mann Methods for sterilizing recombinant or transgenic material
US6908591B2 (en) * 2002-07-18 2005-06-21 Clearant, Inc. Methods for sterilizing biological materials by irradiation over a temperature gradient
US7955788B2 (en) * 2003-10-30 2011-06-07 Medtronic, Inc. Bioprosthetic tissue preparation with synthetic hydrogels
US20050266390A1 (en) * 2004-06-01 2005-12-01 Yuichiro Ueda Processes for removing cells and cell debris from tissue and tissue constructs used in transplantation and tissue reconstruction
US20070218038A1 (en) 2006-03-17 2007-09-20 Pegasus Biologics, Inc. Stabilized, sterilized collagen scaffolds with active adjuncts attached
WO2008073582A2 (en) 2006-10-27 2008-06-19 Edwards Lifesciences Corporation Biological tissue for surgical implantation
US9101691B2 (en) * 2007-06-11 2015-08-11 Edwards Lifesciences Corporation Methods for pre-stressing and capping bioprosthetic tissue
US20090018655A1 (en) * 2007-07-13 2009-01-15 John Brunelle Composite Implant for Surgical Repair
US8357387B2 (en) 2007-12-21 2013-01-22 Edwards Lifesciences Corporation Capping bioprosthetic tissue to reduce calcification
US9387280B2 (en) * 2008-09-05 2016-07-12 Synovis Orthopedic And Woundcare, Inc. Device for soft tissue repair or replacement
EP2674174B1 (en) 2010-03-23 2019-10-16 Edwards Lifesciences Corporation Methods of conditioning sheet bioprosthetic tissue
US8906601B2 (en) 2010-06-17 2014-12-09 Edwardss Lifesciences Corporation Methods for stabilizing a bioprosthetic tissue by chemical modification of antigenic carbohydrates
WO2012027515A2 (en) 2010-08-24 2012-03-01 Southern Lights Ventures 2002 Limited Biomaterials with enhanced properties and devices made therefrom
US9351829B2 (en) 2010-11-17 2016-05-31 Edwards Lifesciences Corporation Double cross-linkage process to enhance post-implantation bioprosthetic tissue durability
US10238771B2 (en) 2012-11-08 2019-03-26 Edwards Lifesciences Corporation Methods for treating bioprosthetic tissue using a nucleophile/electrophile in a catalytic system
US9615922B2 (en) 2013-09-30 2017-04-11 Edwards Lifesciences Corporation Method and apparatus for preparing a contoured biological tissue
US10959839B2 (en) 2013-10-08 2021-03-30 Edwards Lifesciences Corporation Method for directing cellular migration patterns on a biological tissue
CA3116158A1 (en) 2018-11-01 2020-05-07 Edwards Lifesciences Corporation Transcatheter pulmonic regenerative valve

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0037381B1 (en) * 1980-03-31 1984-10-17 Solco Basel AG Method of making organic grafts
US4378224A (en) * 1980-09-19 1983-03-29 Nimni Marcel E Coating for bioprosthetic device and method of making same
EP0124596A4 (en) * 1982-11-12 1985-06-26 American Hospital Supply Corp Chemical sterilization of implantable biological tissue.
US4786287A (en) * 1986-10-10 1988-11-22 Baxter Travenol Laboratories Process for decreasing residual aldehyde levels in implantable bioprosthetic tissue
US5104405A (en) * 1991-02-21 1992-04-14 The University Of Southern California Process for improving the biostability of tissue implant devices and bioprosthetic implants so produced
US5447536A (en) * 1994-02-17 1995-09-05 Biomedical Design, Inc. Method for fixation of biological tissue
KR0131046B1 (en) * 1994-07-13 1998-04-14 김은영 Calcification-resistant tissue heart valve

Also Published As

Publication number Publication date
US5911951A (en) 1999-06-15
AU6056798A (en) 1998-08-26
EP0986405B1 (en) 2003-05-02
WO1998034650A2 (en) 1998-08-13
WO1998034650A3 (en) 1998-10-01
JP2001512333A (en) 2001-08-21
DE69814070T2 (en) 2003-12-18
AU735988B2 (en) 2001-07-26
JP4271262B2 (en) 2009-06-03
EP0986405A2 (en) 2000-03-22
CA2279625C (en) 2008-01-29
DE69814070D1 (en) 2003-06-05

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Effective date: 20170209